Local Quality Manager Getinge Digital Health Solutions

at  Getinge IT Solutions ApS

Local Quality Manager Getinge Digital Health Solutions
Date: Sep 24, 2024
Location:Copenhagen, DK
Company: Getinge IT Solutions ApS
Remote Work: 3-5 days

WITH A PASSION FOR LIFE

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.

JOIN OUR TEAM AS LOCAL QUALITY MANAGER FOR GETINGE DHS

We are looking for an experienced Local Quality Manager (m/f/d) to support our Business Area in the Getinge Digital Health Solutions division (DHS), where we specialize in the development of software for hospitals.
You will be employed at our office located in the Østerbro/Nordhavn area in Copenhagen.
The Local Quality Manager plays a pivotal role in ensuring the highest standards of quality, regulatory compliance, and operational excellence across our organization, with a particular focus on ISO 9001, ISO 27001 and ISO 27701.

ABOUT US

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

THE ROLE

As Local Quality Manager, you will be responsible for overseeing, implementing and continuously improving quality management systems in accordance with regulatory standards and with the Global Getinge QMS. You will work closely with global teams to maintain compliance and readiness for audits while driving a culture of quality throughout the local organization.

KEY RESPONSIBILITIES

• Lead the development, implementation, and maintenance of the QMS and ISMS in line with Getinge requirements and industry standards.
• Oversee regulatory compliance activities, ensuring the organization and products meet all relevant standards such as ISO and others.
• Manage internal and external audits, ensuring continuous improvement and swift resolution of quality issues.
• Provide expert guidance to the team, aligning business processes with regulatory requirements.
• Serve as a key contact for stakeholders, offering strategic insights into regulatory and compliance issues.
• Collaborate with cross-functional teams to ensure organizational alignment on quality and compliance goals.

This role involves leading key QRC projects and collaborating closely with management and our software development department. While most of our products are not classified as medical devices, knowledge of medical device regulations is essential to facilitate discussions and provide solutions in the context of a larger corporation, where the remaining products are medical devices. Additionally, a strong understanding of data privacy and information security is crucial for success in this role.

• Experience: Minimum of 5 years in a quality, regulatory, and compliance management role as well as in information security
• Skills: Strong understanding of regulatory frameworks, proficiency in developing SOPs, excellent problem-solving abilities, and strong communication skills.
• Education: A Bachelor’s degree in Information Technology, further education in Quality Management, Regulatory Affairs or in Information Security.
• Certifications: ISO Lead Auditor certification or equivalent is highly desirable